ANSI/AAMI/ISO 10993-16:2010 (R2014)

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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

Gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

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Association for the Advancement of Medical Instrumentation [aami]

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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

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ANSI/AAMI/ISO 10993-16:2010 (R2014)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

Are the documents at the ANSI Webstore in electronic Adobe Acrobat PDF format only?

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